Street Calls of the Week
IRVINE, California - enVVeno Medical Corporation (NASDAQ:NVNO), trading at $0.78 and down over 85% in the past year according to InvestingPro data, announced Monday it will file a supervisory appeal challenging the FDA’s not-approvable letter for its VenoValve device, which was received on August 19, 2025.
The company plans to submit the appeal before the September 18 deadline, seeking to overturn the Center for Devices and Radiological Health’s decision regarding its Premarket Approval application for the surgical replacement venous valve designed to treat severe deep chronic venous insufficiency (CVI). While InvestingPro analysis shows the company maintains more cash than debt and strong liquidity with a current ratio of 11.81, it faces challenges with rapid cash burn and negative earnings.
"We view this supervisory appeal as an opportunity to extend that relationship," said Robert Berman, enVVeno Medical’s Chief Executive Officer, referring to the company’s previous collaborative interactions with the FDA during the Breakthrough Device Designation and Investigational Device Exemption processes.
The appeal process will involve a formal request, an in-person meeting, and subsequent decision. The company expects a ruling by the end of 2025 and expressed confidence that explaining the physician and patient-reported data from the VenoValve pivotal study to supervisory management would lead to a positive outcome. With a market capitalization of just $15 million and trading below InvestingPro’s Fair Value estimate, the stock’s future appears heavily dependent on regulatory outcomes.
The VenoValve is being developed as a first-in-class surgical replacement venous valve for patients suffering from severe deep venous CVI, a condition that affects an estimated 2.5 to 3.5 million patients in the U.S. who currently have limited treatment options, according to the company’s press release statement. Despite the significant market opportunity, the company’s financial health score remains "FAIR" based on InvestingPro metrics, reflecting both opportunities and risks in its development pipeline.
enVVeno Medical is also developing a non-surgical, transcatheter-based replacement venous valve called enVVe, which is undergoing final testing before seeking FDA approval to begin U.S. pivotal trials.
In other recent news, enVVeno Medical Corporation faced a setback as the U.S. Food and Drug Administration issued a not-approvable letter for its VenoValve device. The FDA determined that the Premarket Approval application for the VenoValve, intended for treating severe deep chronic venous insufficiency, could not be approved in its current form due to insufficient clinical improvement data to establish a favorable benefit-risk profile. Despite this regulatory hurdle, enVVeno Medical shared preliminary findings from a health economic study suggesting that the VenoValve could be a cost-effective treatment option. The study highlighted potential cost savings of $32,442 per patient over five years, prevention of 2.2 venous ulcers per patient, and 0.33 additional quality-adjusted life years gained per patient. These findings indicate potential economic and clinical advantages over standard care treatments. The developments are crucial for investors monitoring enVVeno Medical’s progress in the medical device field.
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